ROBIN ESTRIN

Aug. 08, 1996

BOSTON (AP) _ Three former executives of a medical device manufacturer got 18 months in prison Thursday for selling faulty artery-clearing catheters that were blamed for two deaths.

U.S. District Judge Joseph Tauro handed the maximum sentences to David Prigmore, former executive vice president of C.R. Bard Inc.; John Cvinar, a former division president; and Lee Leichter, a former vice president.

The three men were convicted in 1995 of selling medical devices unapproved by the Food and Drug Administration and conspiring to hide potentially deadly flaws that blocked blood flow to patients' hearts.

In 1993, the company agreed to pay $61 million in criminal and civil penalties and prosecutors have called the case one of the largest health care frauds in U.S. history.

In asking for the tough sentences Thursday, Assistant U.S. Attorney Michael Loucks called the case ``one of evil people doing evil things to innocent people for money.''

The judge, however, refused the prosecution's request to impose fines of $30,000 on each defendant. On Wednesday, he rejected a prosecution request to impose more than the maximum sentences saying it is unclear whether the deaths were caused by the defendants' criminal conduct.

``I don't regard the defendants as being evil people or typical criminal types ... but they did commit a series of crimes in the eyes of the jury, and for that they have to pay the consequences,'' Tauro said Thursday.

Defense lawyers had asked the judge to limit the sentences to one year.

Andrew Good, who represented Leichter, denied that the defendants were trying to make money to the detriment of patients and William Kettlewell, Cvinar's attorney, urged the judge to consider that most patients weren't harmed.

``The good adds up to a lot more than what the jury found,'' said Kettlewell. ``Millions of people were helped by this technology.''

Tauro agreed to delay imposition of the sentences pending the defendants' appeals.

The government alleged that the executives produced and allowed the sale of as many as 20,000 defective catheters between 1987 and 1990.

The catheters are thin, flexible, hollow tubes that a doctor snakes through arteries to an area in the heart that is partly blocked by fatty deposits called plaque. The catheter has a balloon-like tip that is inflated to squeeze the plaque against the artery wall, restoring proper blood flow and preventing heart attacks.

The catheters killed at least two patients when their tips failed to deflate and blocked the flow of blood. In 51 cases, the tips of the catheters broke off inside the patient, in some cases forcing doctors to perform emergency bypass surgery.

Prosecutors said that when doctors reported problems, the company improved the device's design, but failed to report the problems or changes to the FDA, as required by law.

The catheters currently made by Bard are approved by the FDA.

On Wednesday, Tauro rejected a prosecution motion to award $17.1 million to victims of the unapproved heart catheters made by Bard.

Tauro said the catheter had a failure rate of 1 percent, lower than the 1.7 percent rate the FDA had tolerated with catheter tips.

Consumers ``suffered no greater rate of economic harm'' by using Bard catheters than catheters approved by the FDA, Tauro said.

The case was tried in Massachusetts because the catheters were made in Billerica and Haverhill. Three other executives of Bard, which is based in Murray Hill, N.J., were acquitted.

Bard has largely recovered financially from the case, earning profits of $86.8 million last year, a gain of 15 percent, on sales of $1.14 billion.